NCT03515785撤回不适用
A Postmarketing Observational Cohort Study to Evaluate Effectiveness and Safety of Ponatinib (Iclusig®) in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 10
- 主要终点
- Complete hematological remission (CR) rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January
- •Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures.
排除标准
- •Patients previously treated with investigational ponatinib.
- •Patients who are pregnant and/or breastfeeding.
- •Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
结局指标
主要结局
Complete hematological remission (CR) rate
时间窗: 6 months
CR defined as leukemic cells not detectable by light microscopy in bone marrow (BM), peripheral blood (PB), or cerebrospinal fluid (CSF) (BM \< 5% blasts).
次要结局
- CR rate(1, 3, 6, 9, and 12 months)
- Time to CR(Up to 12 months)
- Minimal residual disease (MRD) level(3, 6, 9, and 12 months)
- Duration of molecular response(Up to 12 months)
- Duration of best molecular response (MolCR)(Up to 12 months)
- Daily average dose(Up to 12 months)
- Amount of hospital days(12 months)
- Time to progression(Up to 12 months)
- Time to death(Up to 12 months)
- Best MRD (MolR) level rate(12 months)
- Time to best MRD (MolR) level(Up to 12 months)
- Prescribed dose(Up to 12 months)
- Number of serious adverse events (SAEs)(12 months)
- Number of adverse events of special interest (AESI)(12 months)
研究者
研究点 (10)
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